When anything changes to a product’s make-up or manufacture, a whole chain of events is triggered, starting with an assessment of the regulatory impact in each regulatory jurisdiction, swiftly followed by required actions. Any delay or omission could be costly, so smart process automation offers attractive potential. Regulatory experts Preeya Beczek and ArisGlobal’s Agnes Cwienczek scope the opportunity. 

AI’s potential to transform speed and efficiency, and improve accuracy, has already been demonstrated across a number of Regulatory use cases. These early successes have instilled industry confidence in what the technology can do. Next in companies’ sights is regulatory impact assessment as part of overall product change control (the structured process to assess, document and implement changes to products). Intensifying pressure to bring medicines and updates to market quickly is galvanising Regulatory teams to work in more streamlined ways. Without recourse to artificial intelligence (AI), this is becoming increasingly unviable.